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On 13 July 2023, the U.S. Food and Drug Administration (US FDA) granted Imaging Biometrics, LLC (IB), a wholly-owned subsidiary of IQ-AI Ltd, Orphan Drug Designation (ODD) for gallium maltolate (GaM) for the treatment of pediatric glioblastoma multiforme (GBM). The US FDA also confirmed that an ODD granted to IB in February for adult GBM now applies to all GBM patients.
| Date | 13 Jul 2023 |
| Time | 07:00:03 |
| Category | Corporate updates |
| ID | 8411F |
13 July 2023
IQ-AI Ltd
("IQ-AI" or the "Company")
Orphan Drug Designation for GaM in Pediatric GBM
Imaging Biometrics, LLC (IB), a wholly-owned subsidiary of IQ-AI Ltd (LSE: IQAI, OTCQB: IQAIF), today announced the U.S. Food and Drug Administration (US FDA) has granted Orphan Drug Designation (ODD) for gallium maltolate (GaM) for the treatment of pediatric glioblastoma multiforme (GBM).
In February, IB was granted Orphan Drug Designation for adult GBM. The US FDA has since confirmed that the designation granted in February applies to all GBM patients. GBM is the most common and aggressive primary brain tumor in adults and children. There are currently no effective treatments for pediatric glioblastoma.
Oral GaM recently demonstrated significant survival benefits in a pre-clinical study for pediatric GBM. These promising results, coupled with the easy administration by capsule, make this a very attractive potential treatment option for both pediatric and adult patients.
"We are very pleased that the FDA has now confirmed that the orphan drug designation for GaM applies to all GBM populations including pediatric patients," said Trevor Brown, CEO of IQ-AI.
--ENDS-
The Directors of the Company accept responsibility for the contents of this announcement.
For further information, please contact:
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IQ-AI Ltd Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda Tel: 020 7469 0930 |
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Peterhouse Capital Limited (Financial Adviser and Broker) Lucy Williams/Heena Karani Tel: 020 7220 9797 |
About Imaging Biometrics® LLC: IB is a wholly-owned subsidiary of IQ-AI Limited, (LON: IQAI) (OTCQB: IQAIF), and focuses on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. For more information about Imaging Biometrics, visit the company's website at www.imagingbiometrics.com. Follow IB on Twitter, @IQAI_IB.